Outcome of Symptoms in Patients Undergoing a Heller Myotomy (Achalasia)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
Kenneth Luberice, University of South Florida
ClinicalTrials.gov Identifier:
NCT00519220
First received: August 21, 2007
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

The objective of this study is to review studies and patient symptoms before and after laparoscopic Heller myotomy to assess outcomes following laparoscopic surgery for achalasia.


Condition Intervention
Achalasia
Other: Symptom questionnaire

Study Type: Observational
Official Title: Short and Long Term Outcomes of Heller Myotomy

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • The objective of this study is to review pre-operative and post-operative studies and patient evaluation reports to evaluate patient outcomes following laparoscopic surgery for achalasia [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: December 2006
Estimated Study Completion Date: December 2017
Groups/Cohorts Assigned Interventions
I
Patients will answer symptom questionnaires and have their charts reviewed for relevant medical information.
Other: Symptom questionnaire
Patients will answer questionnaires evaluating their symptoms of achalasia.

Detailed Description:

Patients will answer questionnaires before and after surgery to evaluate their symptoms of achalasia and will also have their charts reviewed for relevant medical information.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital.

Criteria

Inclusion Criteria:

  • Patients with achalasia who have had laparoscopic Heller myotomies for the treatment of achalasia

Exclusion Criteria:

  • No patients under the age of 18 will be included
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519220

Contacts
Contact: Kenneth Luberice 813-844-8219 kluberic@mail.usf.edu
Contact: Carl B Bowers, RN 813-844-7529 ext 7529 cbowers@health.usf.edu

Locations
United States, Florida
Tampa General Hospital/University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Jennifer C. Cooper, B.S.    813-844-4218 ext 4218    jcooper@health.usf.edu   
Contact: Carl B Bowers, R.N.    813-844-7529 ext 7529    cbowers@health.usf.edu   
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Alexander S Rosemurgy, MD University of South Florida
  More Information

No publications provided

Responsible Party: Kenneth Luberice, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT00519220     History of Changes
Other Study ID Numbers: 105235
Study First Received: August 21, 2007
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
achalasia, Heller myotomy

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014